Manufacturer
Lutronic CorporationXERF
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251327
- Device name
- XERF
- Company
- Lutronic Corporation
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-04-30
- Decision date
- 2025-08-11
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
XERF is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Intended Use
XERF is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
XERF is an electrosurgical unit which uses high frequency electrical currents for treatment. When high frequency is irradiated on the skin, the treated skin tissue is heated, resulting in coagulation. This equipment generates high frequency of 2 MHz and 6.78 MHz and is delivered non-invasively into skin through the tip of the handpiece. There are a total of 12 types of active electrode tips compatible with the handpiece; the different tips are intended for various applications and treatment zones. The system also includes a return pad corresponding to the neutral electrode which is intended to be attached to the patient's back to disperse the generated energy. For adjustment of treatment parameter, data can be used by adjusting the operator interface through LCD touch screen. Treatment is conducted using foot switch or finger switch after ready when applied treatment parameter is output to the tissue.
Summary parsed at:2026-06-20 17:49:13 UTC